System and Method for Delivery and Positioning of Surgical Implants

ABSTRACT

Systems and method for delivery and positioning of a sheet-like surgical implant to a target site including a means of deploying and orienting the sheet-like implant within the body.

This application is a continuation-in-part of PCT ApplicationPCT/US2018/016673 filed Feb. 2, 2018, which in turn claims priority toU.S. Provisional Application 62/453,853 filed Feb. 2, 2017.

FIELD OF THE INVENTION

The inventions described below relate to the field of sheet-likesurgical implants.

BACKGROUND OF THE INVENTIONS

Biologic constructs and other sheet-like surgical implants are growingrapidly in popularity for the repair of joint pathologies. “Biologicconstructs” are a family of biologically derived implants to promotetissue growth or to patch and repair tissue defects and tears. These canbe used in the repair of arthritic cartilage, the joining of tendons tobone and the bridging of degenerated rotator cuff in the shoulder.Biologic constructs, which include “regenerative tissue matrices”“acellular tissue matrices” or “collagen scaffolds” and other suchsubstances, are small sheets or disks of flexible, engineeredbiomaterial, such as collagen or fibrin, decellularized dermal matrixcrosslinked and sterilized xenograft tissues, and “platelet-rich-plasma”patches sometimes totally devoid of living cell material and sometimesloaded with active adjuncts such as biologic growth factors. Biologicconstructs may also be tissue-engineered from mesenchymal stem cells.For the purposes of this application, the term biologic construct refersto any sheet-like or disc-like configuration of regenerative tissuematrix, acellular tissue matrices or collagen scaffolds, or similarmaterials suitable for placement within the body to promote healing.

Biologic constructs now occupy an increasingly important place in theorthopedic surgeons armamentarium. One of the key problems with biologicconstructs is that the delivery instrumentation has not kept pace withadvances in these implants. Positioning and alignment is particularly anissue. For example, the biologic constructs are often seeded with cellson only one side, and its very important to attach these implants withcells side down or they will not work. However, both sides look almostthe same so its easy to make the mistake of placing them wrong sidedown.

SUMMARY

The systems and methods described below provide for delivery andpositioning of sheet-like surgical implants adjacent to body tissue. Thedelivery system has a delivery tube assembly and any suitable drivemechanism such as a drive handle or robotic adapter or control system.The delivery tube assembly includes a pushrod shaft with resilientlyexpandable deployment arms positioned at the distal end of a pushrodshaft. The sheet-like implant is releasably secured to the deploymentarms. The sheet-like implant is secured to the arms, and the assembledarms and implant are compressed to fit into the delivery tube, and thedelivery tube is inserted into the body.

The system is modular, with separable drive handle (or drive mechanism)and delivery tube assembly. The delivery system can be equipped withfluid or gas management through the delivery tube assembly. The deliverytube assembly provides for articulation, via either flexible or hingeddeployment, which is especially useful in hernia repair.

This system may be used for both biologic construct delivery inarthroscopy as well as other sheet and scaffold repair procedures. Thesystem may be used for any soft tissue repair procedure where asynthetic or biologic patch is used, such as joint repair or herniarepair. A method for positioning the sheet-like surgical implantadjacent to body tissue is also described.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a and 1b illustrate the sheet-like implant delivery system.

FIGS. 2a through 2f illustrate detailed views of the sheet-like implantfolded on the deployment arms.

FIGS. 3a and 3b illustrate a sheet-like implant delivery system withintegrated fluid management.

FIGS. 4a through 4c illustrate a sheet-like implant delivery system witha straight handle and slider actuator.

FIGS. 5a through 5d illustrate sheet-like implant delivery systems witharticulation.

FIG. 6 illustrates a sheet-like implant delivery system with integratedfluent delivery.

FIGS. 7a and 7b illustrate a sheet-like implant delivery system withthumb and finger loop handle.

FIG. 8 illustrates a sheet-like implant delivery system with integratedendoscope.

FIGS. 9a through 9c are cross sectional views of the distal end of thedelivery system of FIG. 8 taken along 9-9.

FIGS. 10a and 10b illustrate a sheet-like implant delivery system with adrive mechanism for use with a robotic control system adapter.

DETAILED DESCRIPTION OF THE INVENTIONS

FIGS. 1a and 1b illustrate a sheet-like implant delivery system 1comprising a delivery tube assembly 2 and a drive handle 3. The deliverytube assembly 2 comprises a pair of deployment arms 4 attached to thedistal end of a pushrod shaft 5. The pushrod shaft 5 is slidablydisposed within a delivery tube 6. The delivery tube 6 has a retainerfeature (flange 7) for engagement with the drive handle 3. Thedeployment arms 4 are retractable, and may be retracted proximallywithin the delivery tube 6, and are resiliently biased toward the openconfiguration shown in FIG. 1 a, and may be compressed and drawn down toa closed configuration, smaller than the lumen of the delivery tube,when pulled into the delivery tube 6.

The drive handle 3 (or pistol grip) comprises a deployment trigger 8, aspring 9, a retainer slot 10, a drive yoke 11 and a guide slot 12.Engagement between the delivery tube assembly and the drive handle iscreated by slipping the pushrod shaft into the longitudinally orientedpush rod guide slot 11L and pushing the pin 5P into the transverse slot11T of the yoke, and slipping the delivery tube retainer feature (flange7) into the drive handle retainer slot 10. As illustrated, the deliverytube assembly is releasably attached to the drive handle (that is, thedelivery tube assembly can be quickly attached to and detached from thedrive handle without using tools such as screw drivers or wrenches).

The delivery tube assembly 2 allows for a range of implant sizes in onesystem usable with a common drive handle 3. For example, the deploymentarms 4 may be smaller or larger, depending on the size of the implant.The device may be provided in kits, with a single handle and severaldelivery tube assemblies with deployment arms and/or biologic patches ofdifferent sizes, which may be chosen for use by a surgeon duringsurgery, to suit the actual natural or surgically altered anatomy of aparticular patient. The diameter of the delivery tube can be larger orsmaller to accommodate the size of the deployment arms. The deliverytube assembly 2 and the drive handle 3 may be disposable or reusable.

FIGS. 2a through 2c show a close up of the deployment arms 4 with anattached sheet-like implant 13. The sheet-like implant 13 is inserted ina slot 14 within each deployment arm 4, slidably engaging the slots andthus detachably secured to the deployment arms 4. The longitudinal slot14 runs substantially the length of the deployment arm and each slot issized to hold a portion of the sheet-like implant by a friction fitbetween the deployment arm slots and the sheet-like implant. Clamps mayalso be used to attach the implant to the arms. The sheet-like implant13 is folded or rolled as shown in FIGS. 2a through 2d and compressedand loaded within the delivery tube 6 of the delivery system 1. Thedeployment arms 4 and pushrod shaft 5 are positioned within the deliverytube 6. The pushrod shaft 5, with the components assembled, is pulledproximally through the delivery tube 6 prior to delivery into a surgicalspace. The sheet-like implant folds when the user retracts thedeployment arms. Alternatively, the user may manually fold and roll theimplant around the deployment arms prior to retraction within thedelivery tube.

As shown in FIGS. 2d through 2 f, deployment of the implant is performedby manipulating the trigger 8 in the drive handle 3 to extend thepushrod 5 distally from the delivery tube 6 (or pull the delivery tubeproximally, depending on the construction of the handle). Upon fulldeployment distally from the delivery tube, the implant is drawn flat bythe resilient expansion of the deployment arms 4. The sheet-like implantis positioned flat in the desired position and sutured or staked inplace (with other instruments if necessary) or glued in place. Uponpositioning and release of the implant, the arms are retractedproximally through the delivery tube and the delivery system iswithdrawn from the surgical site.

The deployment arms are made of a resilient material (spring metal,nitinol, or plastic) such that they spring open when deployed distallyfrom the distal end of the delivery tube. A first deployment arm and asecond deployment arm each have a proximal and a distal end with theproximal end of each arm coupled to the distal end of the pushrod shaft.The first and second deployment arms are moveable between a closedposition and an open position wherein in the closed position the armsextend generally in the longitudinal direction and in pivoting to theopen position the distal end of each arm moves in a generally transversedirection to spread the sheet-like implant. The distal segments of thearms are arranged in roughly a parallel fashion and a proximal segmentof each arm bends toward the center of the tube to join the pushrodshaft at their proximal ends. An optional holder 25, as shown in FIGS.2E and 2F, may be provided to help hold the implant in place while thedeployment arms are retracted. The holder shaft may be disposed in alumen of the pushrod shaft or the delivery tube, and longitudinallytranslatable within the lumen, extendable distally to the sheet-likeimplant and operable to hold the implant in place.

The delivery tube is rotatable around the pushrod shaft. This allows theuser to manipulate the deployment arms and thus, place the sheet-likeimplant in a desirable position. For example, the user can orient abiologic construct so that the correct side (for example seeded withcells) is placed correctly on the tissue to be treated.

FIGS. 3a and 3b show the implant delivery system with integrated fluidmanagement. A fluid manifold 15 is attached in fluid communication withthe implant delivery tube assembly. The fluid manifold provides forfluid inflow and fluid outflow. Fluid inflow enters in through thedistal end 16 of the device between the deployment arms and fluidoutflow exits from an aperture 17 in the sidewall of the delivery tube.Separate channels may be provided for inflow and outflow. The fluid canbe saline (as in a standard arthroscopic technique) or gas (to becompatible with a tissue adhesive such as fibrin glue).

The implant delivery system can have a straight handle 18 with slideactuator 19 as shown in FIGS. 4a through 4 c. The pushrod shaft is drawnproximally and extended distally by the user correspondinglymanipulating the slider actuator in a proximal and distal direction.

FIGS. 5a through 5d show an implant delivery system with articulation.FIGS. 5a and 5b show a delivery system where the pushrod shaft is aflexible of bendable shaft 20. Flex control is performed via a rotatingwheel 21 controlled by the drive handle. FIGS. 5c and 5d show a hingedpushrod 22 controlled by a rotating wheel 22.

FIG. 6 shows the implant delivery system with a system for delivering afluent medication to the surgical site (for example, tissue adhesives,stem cells, platelet rich plasma (PRP) or medications). Fluentmedications are injected from the fluid source in fluid communicationwith the delivery tube assembly using a pump or syringe 23 operablyconnected to a delivery needle or catheter 24, which is inserted throughthe delivery tube assembly. The fluent delivery can be used, forexample, to place a tissue adhesive under the biologic construct forfixation. The fluent delivery can apply stem cells or PRP to the side ofthe biologic construct contacting the tissue (tendon, cartilage) to betreated.

FIGS. 7a and 7b show an alternate drive handle 25 and delivery tubeassembly 26. The drive handle has thumb 27 and finger loops 28, whichallow the user to exert reverse force on the drive handle to retract thedelivery arms back into the delivery tube.

In use, the surgeon delivers the implant to a joint within the body of apatient by creating an arthroscopic workspace around the joint andinserting a cannula through the skin of the patient proximate thearthroscopic workspace. The surgeon attaches the implant 13 to thedeployment arms 4 and retracts the pushrod shaft 5 with the sheetattached to the deployment arms such that the deployment arms and sheetfit through the delivery tube within the cannula. The surgeon insertsthe delivery tube assembly through the cannula and into the arthroscopicworkspace. The surgeon pulls the drive handle deployment trigger, thuspushing the pushrod shaft 5 in a distal direction to extend thedeployment arms and sheet within the workspace and positioning the sheetproximate an intended site of implantation.

The surgeon then secures the sheet to body tissue within the workspace.The implant is secured with staples, sutures, clips or other means, witha separate instrument. The implant may also be secured with a tissueadhesive deliverable through the delivery tube assembly (as shown inFIG. 6) or a separate instrument. Once the implant is essentially stakedin place, the surgeon releases the implant from the deployment arms bysliding the arms proximally, whereupon the implant is slidably releasedfrom the arms, and the arms withdrawn proximally into the delivery tube.The surgeon retracts the pushrod shaft within the delivery tube andremoves the implant delivery system from the workspace.

FIG. 8 shows the implant delivery system with an integrated endoscope orcamera 31. This allows for visualization of the biologic patch 13through a single portal or a reduced number of portals. The endoscope 31can be conventional, reusable, analog or digital and is operablyconnected to the proximal end of the pushrod shaft 5 and may extendthrough a working channel, a side lumen, or a tube attached on theoutside of delivery tube 6, with the distal end of the endoscopeextending out through the distal end of the delivery tube 6 into thesurgical space. Alternatively, the delivery tube assembly 2 may have abuilt in camera that is disposable with the unit 2. FIG. 8 shows thesystem components as described in FIG. 1A, including the delivery tubeassembly 2, deployment arms 4, pushrod shaft 5, delivery tube 6 anddrive handle 3.

The delivery tube assembly 2 may comprise one or two working channels.FIG. 9a shows, for example, a first working channel 32 and a secondworking channel 33 disposed on the outer surface of the delivery tubeassembly 2. The first working channel may accommodate the endoscopeslidably disposed within the working channel and the second workingchannel operably connected to a delivery needle or catheter 24. FIG. 9bshows a first working channel disposed on the outer surface of thedelivery tube and a second working channel disposed within the pushrodshaft 5. The first working channel may accommodate the endoscopeslidably disposed within the working channel and the second workingchannel operably connected to a delivery needle or catheter 24. FIG. 9cshows one working channel disposed on the outer surface of the deliverytube assembly and a delivery needle or catheter 24 disposed within aside lumen within the wall of the delivery tube 6.

FIGS. 10a and 10b show the delivery system with robotic control systemadapter 34. FIGS. 10a and 10b show the system components as described inFIG. 1A, including the delivery tube assembly 2, deployment arms 4,pushrod shaft 5, pins 5P, delivery tube 6, retainer feature 7. Thedelivery tube assembly 2 may be used with a variety of drive systemssuch as manual handles as previously shown, and may also be used with arobotic control system adapter 34. The delivery tube assembly 2 snapsinto a holder and has features that engage with a motion controlleddriver to advance the deployment arms 4, deploy the implant 13, attachthe implant 13 to tissue with mechanical fasteners, sutures or adhesive,remove the implant from the arms 4, and withdraw the delivery tube 6from the surgical work space. The delivery tube assembly 2 can bereleasably attached and removed from a robotic surgery system.Deployment of the biologic sheet spreader is actuated by the roboticsystem, and the delivery tube assembly 2 has attachment features thatallow the robotic actuator to push the rod and arms 4 within the outertube 6, and to deploy the sheet biologic 13 into the surgical space. Therobotic system may have a robotic actuator that can control thedeployment of the biologic sheet, as well as the deflection of thepushrod shaft 5. The arms 4 may also have a non-stick coating.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the inventions. Thesystem is modular, with separable drive handle and delivery tubeassembly. Alternatively, the system can be assembled as a single unit.The elements of the various embodiments may be incorporated into each ofthe other species to obtain the benefits of those elements incombination with such other species, and the various beneficial featuresmay be employed in embodiments alone or in combination with each other.Other embodiments and configurations may be devised without departingfrom the spirit of the inventions and the scope of the appended claims.

We claim:
 1. A delivery system for delivering a sheet-like implant to asurgical site, said delivery system comprising: a delivery tubeassembly, said delivery tube assembly comprising: a delivery tubecharacterized by a distal end and a proximal end and a lumen extendingfrom the proximal end to the distal end; and a first deployment arm,said first deployment arm having a distal end and a proximal end; asecond deployment arm, said second deployment arm having a distal endand a proximal end; a pushrod shaft having a distal end and a proximalend, said pushrod shaft distal end attached to the first deployment armproximal end and second deployment arm proximal end; and a drive handle;wherein the delivery tube assembly is operably connected to the drivehandle, such that manipulation of the drive handle causes translation ofthe pushrod shaft within the lumen of the delivery tube; and wherein thefirst deployment arm and second deployment arm are resiliently biased toan open configuration wider than the lumen of the delivery tube, andcompressible to a closed configuration in which the deployment arms maybe disposed within the lumen of the delivery tube, and each deploymentarm comprises a longitudinal slot, running substantially the length ofthe deployment arm, each said slot being sized to hold a portion of thesheet-like implant by a friction fit between the deployment arm slotsand the sheet-like implant; and wherein a portion of the pushrod shaftextends proximally from the proximal end of the delivery tube, thedelivery tube assembly further comprises a flange disposed near theproximal end of the delivery tube, and the pushrod shaft furthercomprises a pin disposed on the portion of the pushrod that extendsproximally from the proximal end of the delivery tube; and the drivehandle comprises a retainer slot sized and dimensioned to receive theflange, and fix the delivery tube longitudinally to the drive handle;the drive handle further comprises a trigger operably connected to ayoke, to translate the yoke longitudinally relative to the drive handle,and said yoke comprises a longitudinally oriented slot sized anddimensioned to receive the portion of the pushrod that extendsproximally from the proximal end of the delivery tube and a transverseslot sized and dimensioned to receive the pin of the pushrod, and fixthe pushrod to the yoke, such that, when the delivery tube assembly isattached to the drive handle, manipulation of the trigger causeslongitudinal translation of the pushrod within the delivery tube.
 2. Thedelivery system of claim 1 further comprising: a sheet-like implant,with a first portion of said sheet-like implant disposed within thelongitudinal slot of the first deployment arm and a second portion ofsaid sheet-like implant disposed with the longitudinal slot of thesecond deployment arm.
 3. The delivery system of claim 1 wherein thedelivery tube assembly is releasably attached to the drive handle. 4.The delivery system of claim 1 wherein the pushrod and longitudinal slotof the yoke are configured to rotationally fix the pushrod relative tothe drive handle.
 5. The delivery system of claim 2 further comprising:a holder disposed within the lumen of the delivery tube, said holdercharacterized by a distal end and a proximal end, said holder distal endextending distally from the distal end of the delivery tube, said holderdistal end operably connected to a top surface of the sheet-likeimplant.
 6. The delivery system of claim 1 wherein the delivery tube isrotatable around the pushrod shaft.
 7. The delivery system of claim 1further comprising: a fluid manifold in fluid communication with theimplant delivery tube assembly, said delivery tube further comprising anaperture in a sidewall of the delivery tube near the delivery tubedistal end.
 8. The delivery system of claim 1 wherein: a portion of thepushrod shaft extends proximally from the proximal end of the deliverytube, the delivery tube assembly further comprises a flange disposednear the proximal end of the delivery tube; and the drive handlecomprises a retainer slot sized and dimensioned to receive the flange,and fix the delivery tube longitudinally to the drive handle; the drivehandle further comprises a slide actuator operably connected to thepushrod shaft wherein manipulation of the slide actuator causeslongitudinal translation of the pushrod within the delivery tube.
 9. Thedelivery system of claim 1 wherein the pushrod shaft is bendable nearthe distal end of the pushrod shaft.
 10. The delivery system of claim 1wherein the pushrod shaft is hinged near the distal end of the pushrodshaft.
 11. The delivery system of claim 1 further comprising: a deliveryneedle in fluid communication with a fluid source, said delivery needledisposed within the lumen of the delivery tube, said delivery needlecharacterized by a distal end and a proximal end, said delivery needledistal end extending distally from the distal end of the delivery tube,said delivery needle proximal end operably connected to the fluidsource.
 12. The delivery system of claim 11 wherein the fluid source isa tissue adhesive.
 13. The delivery system of claim 1 wherein the firstdeployment arm distal end is parallel to the second deployment armdistal end.